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Specific Signaling Inhibitor
AEF0117 for Cannabis Abuse (SICA 2 Trial)
Phase 2
Waitlist Available
Led By Matt Evans, MD
Research Sponsored by Aelis Farma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects between 18 and 65 years old, both inclusive.
Subjects must be treatment-seeking and have a mean cannabis use of ≥5 days per week within the last 4 weeks at the screening and baseline visit of the study. Mean cannabis use is assessed by the TLFB and a positive urine concentration test (creatinine-normalized [THC-COOH] ≥50 ng/mL).
Must not have
Subjects taking any of the medications or substances
Timeline
Screening 12 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
SICA 2 Trial Summary
This trial will help study how well a new drug, AEF0117, works in people with cannabis abuse disorders.
Eligible Conditions
- Cannabis Abuse
- Cannabis Dependence
SICA 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You must only use cannabis by inhaling it (smoking or vaping) as your main way of taking it. You can also eat cannabis if you want to.
Select...
Your body mass index (BMI) must be between 18 and 35 kg/m2, which is calculated using your height and weight.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You are currently taking medications or substances that may affect the study results.
SICA 2 Trial Timeline
Screening ~ 12 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days4 visits
Screening ~ 12 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of cannabis use
Secondary outcome measures
Assesment of Quality of life
Complete psychiatric diagnosis
Measures subject-rated intensity of withdrawal symptoms
Other outcome measures
Assessment of Marijuana Craving
Assessment of Quality of sleep
Assessment of desire to quit cannabis
+1 moreSICA 2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AEF0117Experimental Treatment1 Intervention
The current study tests 3 doses of AEF0117 (1.0, 0.3, and 0.1 mg).AEF0117 capsules ; dose range 0.1 to 1.0mg by mouth, once a day for 12 weeks.
Group II: PlaceboPlacebo Group1 Intervention
corn oil capsules once a day for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AEF0117
2022
Completed Phase 2
~80
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Aelis FarmaLead Sponsor
10 Previous Clinical Trials
368 Total Patients Enrolled
1 Trials studying Cannabis Abuse
24 Patients Enrolled for Cannabis Abuse
National Institute on Drug Abuse (NIDA)NIH
2,472 Previous Clinical Trials
2,619,292 Total Patients Enrolled
10 Trials studying Cannabis Abuse
335,158 Patients Enrolled for Cannabis Abuse
Matt Evans, MDPrincipal InvestigatorCEDAR Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking medications or substances that may affect the study results.You must only use cannabis by inhaling it (smoking or vaping) as your main way of taking it. You can also eat cannabis if you want to.If you have had any suicidal behavior or have had thoughts of harming yourself in the past 2 years, you cannot participate in the study. If you had these thoughts or behavior more than 2 years ago, the principal investigator will determine if you are at risk of harming yourself during the study.You must have a moderate to severe cannabis use disorder as determined by a standard assessment tool called MINI-5 based on the DSM-5 criteria.Your body mass index (BMI) must be between 18 and 35 kg/m2, which is calculated using your height and weight.You have had thoughts or made attempts to harm someone else in the past or currently.You are allergic to corn or any food that comes from corn.You regularly take dietary supplements or consume certain foods (like grapefruit juice) that could affect how the study drug works in your body.You have a history of significant medical conditions that could affect your safety during the study or the accuracy of the results. If you have a history of psychiatric disease, there are additional criteria that will be discussed separately.You have been diagnosed with severe depression or any other significant psychiatric disorder, and have not been stable for at least three months with either therapy or medicine. You are currently taking medications that are not allowed for this study.You have been diagnosed with schizophrenia, schizoaffective illness or bipolar disorder. You are currently experiencing psychotic events which require psychiatric intervention or would interfere with the study, except for those caused by substance abuse which are temporary.You have been diagnosed with substance use disorder (except for mild alcohol or tobacco use disorder) in the past year or are currently using opioid agonist or antagonist drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: AEF0117
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 12 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Days after you stop receiving the treatment.
Cannabis Abuse Patient Testimony for trial: Trial Name: NCT05322941 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For this research, is the age limit 45 years or older?
"The age limit to participate in this clinical trial is 65. If a patient is under 18, there are 16 other trials that may be more appropriate. For patients over the age of 65, there are 49 other trials from which to choose."
Answered by AI
Are there any openings for new participants in this research?
"That is correct, the clinicaltrials.gov website indicates that this research is actively looking for subjects. The study was originally published on May 6th, 2022 and was most recently updated on June 1st, 2022. There are 8 different locations where the researchers are hoping to enroll 330 people in total."
Answered by AI
If I wanted to participate in this research, would that be possible?
"This trial is testing the effects of a new medication on hashish abuse in adults aged 18 to 65. A total of 330 individuals will be enrolled in this study."
Answered by AI
When might AEF0117 receive FDA approval?
"AEF0117's safety is estimated to be a 2. While there have been Phase 2 trials conducted which support the medication's safety, there is no data currently available which supports its efficacy."
Answered by AI
Are there many hospitals conducting this trial in Canada?
"Enrollment for this study is currently happening at Segal Trial in Lauderhill, Florida; The Substance Treatment and Research Service (S.T.A.R.S.) of Columbia University/NYSPI in New york, New York; UCLA Department of Psychiatry and Biobehavioral Sciences in Los Angeles, California; as well as 8 other additional locations."
Answered by AI
What is the sample size of this experiment?
"The trial sponsor, Aelis Farma, needs to enroll 330 eligible patients from various clinical sites including Segal Trial in Lauderhill, Florida and The Substance Treatment and Research Service (S.T.A.R.S.) of Columbia University/NYSPI in New york City."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
California
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Behavioral Clinical Research
Other
UCLA Department of Psychiatry and Biobehavioral Sciences
Segal Trial
How many prior treatments have patients received?
1
0
What questions have other patients asked about this trial?
How many days a week and what days?
PatientReceived no prior treatments
Why did patients apply to this trial?
I want to quit. Because I wanna quit. I been smoking since teenager. I will like to see the effectiveness of the studie.
PatientReceived 1 prior treatment
Because I'm highly interested in stopping the use of cannabis.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
- UCLA Department of Psychiatry and Biobehavioral Sciences: < 24 hours
- CenExel CNR: < 24 hours
- Segal Trial: < 48 hours
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